Funds
Available and Anticipated Number of Awards. NIAID anticipates awarding a total of
$2.8 million in FY 2009 to fund 1-2 new awards.

Budget
and Project Period. Budget limitations for individual applications are
specified in the RFA. The total project period for an application submitted in
response to this FOA may not exceed five years.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals
with the skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Number of Applications. Applicants may submit more than one
application, provided they are scientifically distinct.

Resubmissions. Resubmission applications are
not permitted in response to this FOA.

Renewals.Renewal applications are not permitted in response to this FOA.

The National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH), invites
applications from consortia of institutions/organizations to participate in the
Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP). This
program is designed to move new therapeutic concepts from the laboratory bench
to the clinic for initial testing. The multi-project cooperative
agreement (U19) mechanism is being used to encourage multidisciplinary,
collaborative research efforts involving NIAID, academia, the private sector,
and external scientific advisors.

Research advances in recent years have
yielded a wealth of information on HIV molecular biology, the pathogenesis of
HIV disease, and the impact of disease progression on immune function.
Concomitantly, important methodological advances have been made. Together
this scientific and technological progress has made possible the exploration of
a wide range of non-traditional therapeutic concepts, as well as traditional
drug-based therapies exploiting novel viral and cellular targets. In the
preclinical area this RFA seeks research on: new therapeutic targets, novel
inhibitors of viral or cellular proteins or pathways critical to HIV
replication and/or persistence, and immunological approaches to complement
antiretroviral-based therapies. Animal model studies are
encouraged. In the clinical area the focus is on iterative
bench-to-bedside research to pilot new therapeutic approaches. Phase I or
I/II clinical studies (10-30 subjects) may be included to demonstrate
proof-of-concept.

Background

Since the mid-1980’s NIAID
has encouraged investigators from academia and the private sector to work
together to find new therapies for HIV infection through such programs as the
National Cooperative Drug Discovery Groups (NCDDG), the Strategic Program for
Innovative Research on AIDS Treatment (SPIRAT), and the current IPCP.
Such partnerships have explored a number of novel targets and discovered
entities/strategies that have been evaluated in HIV-infected subjects. A
list of projects supported under previous issuances of the IPCP can be found
at: http://www.niaid.nih.gov/daids/pdatguide/ipcp.htm.
This site also contains examples of accomplishments attributable to the IPCP
and similar multi-project programs supported by NIAID, Division of AIDS
(DAIDS).

In an era of complex
antiretroviral treatment regimens, the development of resistance, toxicities,
and drug interactions will continue to be problematic as new agents are
introduced. Moreover, extensive research has shown that combination
antiretroviral therapy cannot totally eliminate HIV-1 and only partially
reverses immune system damage. Thus, while efforts to develop effective
prevention and treatment modalities for HIV infection continue, there remains a
need for the identification/validation of new host and viral targets, novel
drugs and delivery systems, immunological approaches to contain HIV infection,
and agents/strategies to eliminate viral reservoirs.

Research Objectives and Scope

The objectives of the IPCP are to
support: (1) innovative preclinical studies to identify new HIV therapies, and
(2) the translation of innovative treatment concepts to the clinic for
proof-of-concept studies. Applicants are expected to have an identified
strategy based on a solid scientific rationale and supported by preliminary
data. Applications may propose: (1) preclinical research
exclusively, or (2) iterative bench-to-bedside research that involves one or
more pilot scale clinical studies (10 - 30 subjects).

Examples of research topics of interest for this RFA:

Validation
of new therapeutic targets

Targeted
screening of chemical or natural product libraries or collections, to identify
inhibitors of viral or cellular proteins or pathways critical to HIV replication/persistence

Concepts
or drug entities that are ready for clinical trial without further
research. Such projects can be pursued under another NIAID mechanism,
i.e. clinical planning and implementation grants (see http://www.niaid.nih.gov/ncn/clinical/R34.htm)

Partnerships

A key component of this initiative is the formation of partnerships
between academia and the private sector. For the purpose of this RFA, the
term “private sector” comprises large and small, domestic and
foreign, for-profit and non-profit pharmaceutical, biotechnology,
bioengineering, and chemical companies. Each application must be composed
of a minimum of three interrelated research projects and an Administrative
Core; one or more Scientific Cores may be proposed. At least one research
project must be contributed by the private sector partner if the applicant
institution is from academia; conversely, at least one research project must be
contributed by an academic partner if the applicant institution is from the
private sector. Applications not meeting the above described
requirements, with regard to number and types of projects/cores, will be
considered non-responsive and the application will not be reviewed.

The private sector partner must propose a research plan that
contributes materially and intellectually to the overall goals and objectives
of the program. The requirement for a private sector component is not met
by entities providing only research resources for the project, such as reagents
and novel experimental therapeutics, or service-type activities as described
below under Scientific Cores. Projects from a private sector partner
proposing to provide only resources or services, even if unique, will be deemed
non-responsive, and the application will not be reviewed.

Applicants are encouraged
to reach early consensus with any proposed partners regarding intellectual
property, data sharing, and other legal matters that may arise during the
project. In addition, applicants are expected to exercise their Bayh-Dole
rights in a manner that does not conflict with the goals of this award or the
intent of the Bayh-Dole Act to promote the utilization, commercialization and
availability of U.S. Government-funded inventions for public benefit.
Finally, applicants are expected to make new information and materials known to
the research community in a timely manner through publications, web
announcements, and reports to NIAID or other mechanisms (see Section VI.2.A.1. for Principal Investigator (PI)
responsibilities related to Intellectual Property and Section
IV.6. for requirements related to sharing research data and resources).

Scientific Cores

One or more scientific cores
may be proposed. A scientific core is a
resource to the multi-project grant as a whole and must support at least two of
the proposed research projects. The application must indicate the
specific projects to be served by the scientific core(s). Typically a
core performs a service-type activity rather than hypothesis-driven
research. Examples of services that could be provided by
such cores include: routine in vitro assays, cell processing and preparation, standard
pharmacology and toxicology tests.The placing of clinical trials or other significant
clinical activity in a core is not appropriate; applications structured in this
manner will be deemed non responsive and not reviewed.

This funding
opportunity will use the U19 award
mechanism(s). The
Project Director/Principal Investigator (PD/PI) will be
solely responsible for planning, directing, and executing the proposed project.

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement
mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner with
the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award."

2. Funds Available

The estimated amount of funds available for support of 1-2projects
awarded as a result of this announcement is $2.8
Million for fiscal year 2009. Future
year amounts will depend on annual appropriations.

An applicant may request a project period of up to five years and a
budget for direct costs that respects the following limits: for applicants
proposing exclusively preclinical research throughout the five year term,
$650,000 direct costs for the first year; for applicants proposing the use of
large animals (e.g. non-human primates), up to $775,000 direct costs in any
year(s) that such large animals will be needed; and for applicants proposing clinical
studies, up to $1.3 million direct costs in any year(s) in which clinical
studies are being conducted. Applications not adhering to the stated
budget limits will not be reviewed.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.

PIs,
Project Leaders, and Core Leaders are requested to commit substantial time and
effort to ensure success of the multi-project program. It is recommended
that these individuals devote a minimum of 2.4 calendar months annual
effort. This level of commitment can be all in one project or core or a
total effort across several projects/cores within a single application.

Applications
for supplements to existing projects are not eligible to compete under this
FOA.

Applicants are not permitted to submit a resubmission
application in response to this FOA.

Renewal applications are not permitted in response to this
FOA.

Applicants
may submit more than one application, provided each application is
scientifically distinct.

Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
for the primary applicant institution should be entered on line 11 of the face
page of the PHS 398 form.

The title and number
of this funding opportunity must be typed in item (box) 2 only of the face page
of the application form and the YES box must be checked.

Supplemental
Instructions for the Preparation of Multi-Project Applications

The following section supplements the
instructions found in the PHS Form 398 for preparing the multi-project grant
application. Additional instructions are required because the PHS Form 398 is
designed primarily for individual, free-standing research grant (R01)
applications, and has no specific instructions for multi-project applications
consisting of research projects interrelated by a common theme.

The supplemental instructions below
are divided as follows:

A. General Instructions – addresses collaborative efforts among research
projects, the administrative and organizational structure as well as the
overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Projects – describes modifications
to PHS Form 398 instructions on selected items to address the collaborative or
interactive role of the project.

C. Specific Instructions for Core Units – Cores must provide
services or resources to support at least two research projects. Instructions
describe modifications to PHS Form 398 instructions on selected items to
address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant
application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page
of the entire application and all succeeding pages should be numbered
consecutively.

2. Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description
(abstract) of the OVERALL multi-project application addressing the major,
common theme of the program. Do not exceed the space provided.

List the performance sites where the
research will be conducted.

Under "Key Personnel", list the Principal Investigator of the
multi-project application, followed by the Project Leaders of the component
research projects and cores, other key personnel, and then other significant
contributors.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents
is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by
project and core by core, prepare a detailed Table of Contents that will enable
reviewers to readily locate specific information pertinent to the overall
application as well as to each component research project and core. A page
reference should be included for the budget for each project and each core.
Further, each research project should be identified by number (e.g. Project 1),
title, and responsible Project Leader, and each Core should be identified by
letter (e.g. Core A), title, and responsible Core Leader. The page location of
a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4. Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format
presented below, prepare a composite budget for all proposed years of support.
(Justification for budget elements should not be presented here but in the
individual budgets of the projects and cores.)

SAMPLE:
Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year
1

Year
2

Year
3

Year
4

Year
5

All
Years

Project
1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project
2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project
3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core
A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core
B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

5. Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods
(years) and the Total Direct Cost for Entire Period of Support entry.

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should
be placed at the end of the application with the Principal Investigator first,
followed by those of other key personnel in alphabetical order.

7. Other Support Format Page

Do not complete. (Any required
information will be requested from successful applicants prior to grant award.)

8. Resources Format Page

Do not complete. Essential information
is to be presented in the individual research project and core sections of the
application.

9. Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the
multi-project application and is limited to 25 pages. The multi-project
application should be viewed as a confederation of interrelated research
projects, each capable of standing on its own scientific merit, but
complementary to one another. This is an important section for it provides the
group of investigators an opportunity to give conceptual wholeness to the
overall program – by giving a statement of the general problem area and
by laying out a broad strategy for attacking the problems. As the strategy
develops, each project and core should be cited briefly as to its place in the
overall scheme. Summarize the special features in the environment and/or
resources that make this application strong or unique.

10. Checklist

One Checklist, placed at the end of
the application, is to be submitted for the entire application.

11. Resource Sharing Plan

One Resource Sharing Plan, placed at
the end of the application, is to be submitted for the entire application.

B. Specific Instructions for Individual Research Projects

1. Cover Page

The Face Page of the PHS 398 Form should
not be used as a cover page for individual research projects within a
multi-project application. Instead, use the PHS 398 continuation page to create
a

"Cover Page" containing
selected data about each individual research project. This Cover Page will
demarcate each individual research project and should contain the following
information items (these are a subset of the information provided on a PHS 398
Face Page):

Provide a Description (abstract) of the research proposed in the project according to the
instructions on Form Page 2 of the PHS 398. In addition, the abstract should
contain a brief description of how the research project will contribute towards
attainment of the multi-project program objectives.

List the performance sites where
the research will be conducted.

Under "Key Personnel", list the Principal Investigator of the
multi-project application, followed by the Project Leaders of the component
research projects and cores, other key personnel, and then other significant
contributors.

3. Form Page 3

Prepare a Table of contents for the research project using Form
Page 3 of the PHS 398.

4. Biographical Sketches

Do not repeat the biographical sketches of participating investigators
since this information will be included at the end of the overall application
(and therefore will be referenced in the Overall Table of Contents).

5. Research Plan (Items 2-5 cannot exceed 25 pages)

Item 2 --
Specific aims: List in priority order, the broad, long-range
objectives and goals of the proposed project. Concisely and realistically
describe the hypothesis or hypotheses to be tested. In addition, state the
project's relationship to the multi-project program goals and how it
relates to other projects or cores. This section is typically one page.

Item 3 --
Background and significance: Use this section to describe how
the proposed research will contribute to meeting the program's goals and
objectives and explain the rationale for selecting the methods to
accomplish the specific aims. In addition to stating the biological
significance of the research, indicate the project's relevance to the
primary theme of the application.

7. Resource Sharing Plan. Do not
create a resource sharing plan for an individual project.

For all other items in the
individual research project application, follow the usual PHS 398 instructions.

C. Specific
Instructions for Cores

Administrative Core. Each application must include an Administrative Core
headed by the Principal Investigator or other senior investigator and must
describe the overall management, coordination and supervision of the
program. Provide an administrative plan discussing the structure and
roles of administrative staff, including the training and experience of
proposed staff and the functions they will perform; how fiscal and other
resources will be prioritized, allocated and managed; how communications will
be facilitated; and how research-related travel and training will be budgeted.
Funding for the overall administrative efforts, including secretarial, and/or
other administrative services, expenses for publications demonstrating collaborative
efforts, communication expenses, etc., should be requested here.
Estimated expenses for travel of the Scientific Advisory Panel members should
be based on one group meeting per year and should be included in the
administrative core budget. Estimated expenses for travel of the Project
and Core Leaders to the annual group meeting should be included in the
respective project and core budgets. No travel funds will be allowable
for attendance to other domestic or foreign scientific meetings.

Scientific Cores. A scientific core is a resource to the multi-project
grant as a whole and must support at least two of the proposed research
projects. The application must indicate the specific projects to be served by
the Scientific Core(s). This section of the application should present a
clear picture of the facilities, techniques, and skills that the core will
provide and describe the role of the Scientific Core Leader and each of the key
participants. The apportionment of dollars, or percentage of dollars,
that will be required to support each component research project which will
utilize each scientific core should also be presented.

All Cores

Cover Page. The Face Page of the PHS
398 Form should not be used as a cover page for cores within a multi-project
application. Instead, use the PHS 398 continuation page to create a "Cover
Page" containing selected data about each individual core. This Cover Page
will demarcate each core and should contain the following information items
(these are a subset of the information provided on a PHS 398 Face Page:

Form Page 2. Provide a Description (abstract) of the core activities and services according to the instructions on
Form Page 2 of the PHS 398. In addition, the abstract should contain a brief
description of how the core services will contribute towards attainment of the
multi-project program objectives.

List the performance sites where the
research will be conducted.

Under "Key Personnel", list the Principal Investigator of the
multi-project application, followed by the Project Leaders of the component
research projects and cores, other key personnel, and then other significant
contributors.

Form Page 3. Prepare a Table of Contents for the core using Form Page 3
of the PHS 398.

Biographical Sketches. Do not repeat
the biographical sketches of participating investigators since this information
will be located at the end of the overall application (and therefore will be
referenced in the Overall Table of Contents).

Core
Research Plan (Items 2-5 cannot exceed 25 pages)

Item 2 - Specific Aims: List in priority order, the broad, long-range
objectives of the proposed core. In addition, state the core's
relationship to the multi-project program goals and how it relates to the
research projects or other cores in the application.

Item 3 -
Background and Significance: Use this
section to describe how the proposed core activities will contribute to
meeting the program’s goals and objectives and explain the rationale
for the selection of the general methods and approaches proposed to accomplish
the specific aims. In addition, this section should indicate the relevance
of the core to the primary theme of the multi-project application.

Appendix. Do not create an appendix for a core.

Resource Sharing Plan. Do not create a resource
sharing plan for a core.

For all other items in the
individual core application, follow the usual PHS 398 instructions.

Foreign Organizations

Foreign institutions/organizations are not eligible to
apply as the primary applicant, but may enter into a consortium with a domestic
[U.S.] institution/organization and participate as a component (project or
scientific core).

Every effort should be made to
comply with the format specifications, which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% Facilities
and Administrative (F&A) costs (excluding equipment) may be requested.
SeeNOT-OD-01-028, March 29,
2001.

Organizations must comply with
Federal/NIH policies on human subjects, animals, and biohazards.

Organizations must comply with
Federal/NIH biosafety and biosecurity regulations. See Section
VI.2.,
“Administrative and National Policy Requirements”

Proposed research should provide special opportunities for
furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions in other countries that are not
readily available in the United States or that augment existing U.S. resources.

Applications
with Multiple PDs/PIs

Not Applicable.

3. Submission Dates and Times

Applications
must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal
Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at
the beginning of this document.

Applications
must be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, andthreesigned
photocopies in one package to:

Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the NIAID.Incomplete and non-responsive
applications will not be reviewed.

The NIH will not accept any
application in response to this funding opportunity that is essentially the
same as one currently pending initial review, unless the applicant withdraws
the pending application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to a funding opportunity, it is to be prepared as a NEW
application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded version
of the application.

Information on the
status of an application should be checked by the Principal Investigator in the
eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review

All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at NIH Grants
Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new award.

The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The release of funds for any clinical study will be contingent
upon compliance with NIH, NIAID, and DAIDS policies and procedures for clinical
research and those of applicable institutional and regulatory bodies
[Institutional Review Board (IRB), Institutional Biohazard Committee (IBC),
Food and Drug Administration (FDA), Recombinant DNA Advisory Committee (RAC),
other]. See Section VI. 2.A.1.c.

6. Other Submission Requirements and Information

Research
Plan Page Limitations

Standard page limitations apply; items 2-5 of the project or
core research plan may not exceed 25 pages.

Applications must include the following, which are to be
placed in the appropriate sections as indicated:

Development Plan (Place in Overview): A plan articulating a set of goals and milestones to be
completed during the term of the project, and a time table for achieving them.
For projects that have a clinical component, the goals and milestones will be
used to judge the readiness of the Group to proceed to the clinical phase. This
decision i) will be made by NIAID and may involve the applicant’s
Scientific Advisory Panel and/or other outside experts, and ii) will be based
on a review of the preclinical data generated to support the clinical study,
the clinical protocol, and the status of the budget.

Clinical study
plan, if applicable (Place in
appropriate research project): Applicants must address the following
elements: study design, rationale for the design, study objectives, study
population, statistical design and analysis, management and quality control of
data, receipt and storage of human samples, proposed clinical sites and
investigators. Recognizing that the details of the study will change as a
result of scientific progress and as a function of review by various
institutional and Governmental bodies, a formal protocol is not requested.
However, applicants must address all NIH-required human subjects issues,
including protection against research risks and gender, minority, and child
representation in the human subjects section of the application as described in
the PHS 398 application instructions.

Applications that do not include a development plan and a
clinical study plan (if applicable) will be deemed non-responsive and will not
be reviewed.

Awardees must agree to
the “Cooperative Agreement Terms and Conditions of Award” in
Section VI.2.A. “Award Administration Information”.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources
developed through NIH-sponsored research an important means to enhance the
value of, and advance research. When resources have been developed with NIH
funds and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final
data/resources are not amenable to sharing, this must be explained in Resource
Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms: Regardless of
the amount requested, all applications where the development of model organisms
is anticipated are expectedto include a description of a
specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate
reasons why such sharing
is restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested,
applicants seeking funding for a genome-wide association study are
expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate explanation why
submission to the repository is not possible. A genome-wide association
study is defined as any study of genetic variation across the entire genome
that is designed to identify genetic associations with observable traits (such
as blood pressure or weight) or the presence or absence of a disease or
condition. For further information see Policy for Sharing of Data
Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

NIAID recognizes that the
data and information generated through the IPCP Program will be extremely
valuable to other researchers and that the rapid sharing of these data will be
essential in advancing research to facilitate the development of therapeutics,
vaccines and diagnostics. Sharing of data and information with the broad
scientific community relies upon the awardees making such data and information
available by depositing them into publicly accessible data repositories.
NIAID has established data release guidelines for other programs, including the
Centers of Excellence for Influenza Research and Surveillance http://www3.niaid.nih.gov/research/resources/ceirs/ and the Microbial Sequencing Centers http://www.niaid.nih.gov/dmid/genomes/mscs/default.htm.

Genomic sequences data
sets generated with IPCP funding are required to follow the NIAID Data Release
and Usage Plan (http://www.niaid.nih.gov/dmid/genomes/mscs/data_release.htm),
which provides for releasing sequence data within 45 calendar days of being
generated to Genbank, a publicly searchable, international database of genetic
sequences provided by the NIH National Center for Biotechnology and
Information.

Other genome-wide or
proteome-wide data sets including, but not limited to, functional genomics,
proteomics, metabolomics, glycomics data sets should be made available through
a publicly accessible web site(s), such as one of the NIAID Bioinformatics
Resource Center or other relevant sites as determined by the NIAID Program
Officers; this must be done within 2 months of publication or within 1 year of
generation, whichever comes first. Examples of genomics or proteomics data
sets that should be made available to the broad scientific community include
annotation and functional characterization of genes and their products, gene
and protein expression data, mass spectrometry data, siRNA data, SNPs and other
genetic variation data, genotype and phenotype associations.

All applicants must include
a plan for sharing genomics, proteomics and other types of research data in
their application. Those responding to this funding opportunity
announcement must include a description of how such research data will be
shared, or explain why data sharing is not possible.

The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.

Final details of the data
release plan must be negotiated between NIAID and each awardee to assure that
the planned data releases are consistent with the guiding principles stated
above. Final approval for the data release plans will be given by NIAID prior
to award. Updates to the Plan will have to be submitted to NIAID as part of the
Annual Progress Report. The NIAID Program Staff will review the updated
Plan for approval with modifications as needed.

It is recognized that
each scientific project may pose specific opportunities or challenges with
respect to public data release. Therefore efforts will be made to tailor
the data release guidelines to accommodate specific situations and needs as
plans are negotiated between awardees and NIAID program staff.

Section V. Application
Review Information

1. Criteria

Only
the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are
complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NIAID in accordance with NIH peer review
procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the scientific peer review, all applications
will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score.

Receive
a written critique.

Receive
a second level of review by the National Advisory
Allergy and Infectious Diseases Council.

The following will be considered in making funding
decisions:

Scientific
and technical merit of the proposed project as determined by peer review

Availability
of funds

Relevance
of the proposed project to program priorities

The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Review Criteria for the Overall Application

The following items will be considered
in the determination of overall scientific merit and priority score for the
entire application:

Overall score: a single numerical
priority score will be assigned to the whole application after consideration of
all of the elements. The overall score for the application will be based
primarily on the scientific merit of the individual components, with additional
consideration of the overall synergy and integration of the components, the
overall program organization, and the capabilities of the associated personnel.

Significance: Does this study address an important
problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of
these studies on the concepts, methods, technologies, treatments, services, or
preventive interventions that drive this field?

Is the
program as a whole, as well as that of the individual research projects and
scientific cores, scientifically meritorious?

Are the
overall program goals and milestones significant and appropriate?

Will
combining the component projects into a multi-project program result in
scientific gain beyond that which is achievable if each project were to be
pursued independently?

Approach: Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics?

Is
the overall program cohesive?

Are
the multi-disciplinary scope of the program and the coordination and
interrelationships for all individual research projects and scientific core(s)
appropriate and focused on the common theme?

Is there sufficient information given about the chemical
structure, physical/chemical, and pharmacologic properties of proposed small
molecule HIV inhibitors for reviewers to judge their potential toxicities and
drugability?

Innovation: Is the project original and innovative?
For example: Does the project challenge existing paradigms or clinical
practice; address an innovative hypothesis or critical barrier to progress in
the field? Does the project develop or employ novel concepts, approaches,
methodologies, tools, or technologies for this area? Is a novel
therapeutic target identified or validated?

Investigators: Are the investigators appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator and other
researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?

Does
the PI possess the leadership skills and scientific ability to develop,
oversee, and implement a program of integrated research projects with a
well-defined central research focus?

Has
the PI devoted adequate time and effort to the program?

Environment: Does the scientific environment in
which the work will be done contribute to the probability of success? Do
the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

Review Criteria for the Individual Research Projects

Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the
effect of these studies on the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to their level of experience? Does the investigative
team bring complementary and integrated expertise to the project (if
applicable)? If from the same academic institution or
company as the PI or other Project Leaders, has the Project Leader demonstrated
the ability to direct an independent research program?

Environment: Does the scientific environment in
which the work will be done contribute to the probability of success? Do
the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

Review
Criteria for Cores

Administrative
Core

Is the administrative and organizational structure appropriate
and sound to facilitate attainment of the objective(s) of the proposed program?

Is the management plan for fiscal
accountability and communications within the overall program appropriate?

Are the
plans for coordination, problem identification and resolution, and the
establishment of a strong collaborative environment for the program
appropriate?

Scientific Research Cores

Are the justification and usefulness of
the core facilities to the individual research projects appropriate and sound?

Is the relationship of each core to the
central focus of the overall program strong?

Are the quality of the relevant
facilities or services provided (including procedures, techniques, and quality
control) and criteria for prioritization and usage appropriate?

Are the qualifications, competence, and
commitment of the Scientific Core Leader and key personnel appropriate?

In addition to the above review criteria, the following
criteria will be applied to applications in the determination of scientific
merit and the priority score.

Private sector
partner. Did the private sector partner propose a research plan that
contributes materially and intellectually to the overall goals and objectives
of the program? Is it committed to the development of the
proposed therapeutic entity or modality? Will it provide expertise and/or
resources not generally available in academia?

Groups proposing
exclusively preclinical research. Is it likely that the
proposed target/strategy can be advanced toward clinical evaluation during the
award period?

Groups proposing
clinical research. Is the timeline for initiating
the clinical studies realistic? Has the group provided milestones that
can be used to assess their readiness to begin human studies? Have they
provided a short and long term development plan?

2.A. Additional Review Criteria:

In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:

Protection
of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).

Inclusion
of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).

Care
and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.

Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.

2.B. Additional
Review Considerations

Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

2.C. Resource
Sharing Plan(s)

When relevant, reviewers will be
instructed to comment on the reasonableness of the following Resource Sharing
Plans, or the rationale for not sharing the following types of resources.
However, reviewers will not factor the proposed resource sharing plan(s) into
the determination of scientific merit or priority score, unless noted otherwise
in the FOA. Program staff within the IC will be responsible for monitoring the
resource sharing.

After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.

If the application
is under consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification
in the form of a Notice of Award (NoA) will be provided to the applicant
organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official (designated in item 12 on the
Application Face Page). If a grantee is not email enabled, a hard copy of the
Notice of Award will be mailed to the business official.

Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award

The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.

The
administrative and funding instrument used for this program will be the Multi-project
Cooperative Agreement (U19), an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The
Principal Investigator will have the primary responsibility for:

a) Annual Meeting: The Principal
Investigator (PI) will be responsible for scheduling the time and place of an
annual meeting of the group (PI, Project and Core Leaders), the Scientific
Advisory Panel, and NIAID Scientific Coordinator (SC) to review progress, plan
and design research activities, and establish priorities.

b)
Scientific Advisory Panel: The PI will constitute a Scientific Advisory
Panel of 2-3 investigators, not affiliated with any of the institutions
comprising the Group, within six months of the award. The Panel will
review progress and make recommendations as appropriate. The Panel will
provide the PI with a comprehensive written evaluation of the group's activities
after each meeting; a copy of the Panel's report will be sent by the PI to the
SC within thirty (30) days of each annual meeting. For awards involving a
clinical study, the Panel, at the discretion of NIAID, may be called upon to
help determine the readiness of the group to initiate the study.

d) Communication: The PI will communicate with the SC on a
regular basis regarding the status of the ongoing research. Importantly,
the PI will communicate with the SC regarding the conduct of any clinical
activity (enrollment, adverse events, interactions with the FDA, problems and
resolutions of the same, changes of personnel, protocol amendments, etc.).

e) Intellectual Property:

If
needed for the research project(s), the awardee shall be solely responsible for
the timely acquisition of any proprietary rights, including intellectual
property rights, and all materials appropriate for the applicant to perform the
project(s).

The
awardee acknowledges that prior to, during, and subsequent to the award, the
U.S. Government is not required to obtain for the awardee any proprietary
rights, including intellectual property rights, or any materials needed by the
awardee to perform the project(s).

The
awardee acknowledges the requirement to report to the U.S. Government all
inventions made in the performance of the project(s), as specified at 35 U.S.C.
Sect. 202 (Bayh-Dole Act). In addition, awardees are expected to exercise
their Bayh-Dole rights in a manner that does not conflict with the goal of this
award or the intent of the Bayh-Dole Act to promote the utilization,
commercialization and availability of U.S. Government-funded inventions for
public benefit.

Awardees
are expected to make new information and materials known to the research
community in a timely manner through publications, web announcements, and
report to the NIAID or other mechanisms consistent with laws, regulations, and
NIH policies.

Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.

f) Annual progress report: The PI will submit an annual progress
report including results of the activities of all components of the grant
(projects and cores); a summary outlining interactions among group members and
with NIAID; and a complete, cumulative list of all publications authored by
group members.

g) Presentations or publications: The PI is responsible
for the timely presentation/publication of work supported in part or in whole
by this Cooperative agreement. Appropriate acknowledgement of NIAID
support under the IPCP is required.

2.A.2. NIH Responsibilities

An
NIAID Scientific Coordinator (SC) will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below.

A SC will provide a liaison function between the awardee and the
NIAID. Ordinarily a single extramural SC will be the contact for all
facets of the scientific interaction with the awardee. As required for the
coordination of activities and to expedite progress, the SC may designate
additional NIAID staff to provide advice or assistance to the awardee on
specific scientific, medical, technical, or management issues. The SC
shall retain overall programmatic oversight for the award and will clearly
specify to the awardee the name(s) and role(s) of any such additional
individuals and the lines of reporting authority.

During performance of the award, the SC may provide assistance,
advice, and guidance by: participating in the design of activities;
facilitating access to resources and information that otherwise might not be
available; advising in the management of the projects and technical
performance; facilitating interactions between the awardee and other groups of
importance to the awardee, for example the AIDS Clinical Trials Network, the
FDA, pharmaceutical and/or biotechnology companies, and other investigators
with similar interests; providing guidance and oversight on compliance with
Federal regulations related to human subjects research and NIAID policy on
clinical research, and communicating in a timely fashion information that might
affect the safety of subjects in grant supported studies; and participating in
the annual site visit as a partner, to review research progress and direction
and provide recommendations. However, the role of NIAID will be to
facilitate and not direct the activities. It is anticipated that
decisions in all activities will be reached by consensus and that NIAID program
staff will be given the opportunity to offer input into this process. The
manner of reaching consensus and the final decision-making authority will rest
with the PI.

Additionally, an agency program official or IC program
director will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice.

2.A.3.
Collaborative Responsibilities

Open communication throughout the duration of the award
regarding all aspects of group activity, positive and negative.

Participation in an annual meeting of the IPCP group, its
SAP, and assigned NIAID staff to review the status of the group’s
scientific progress and interaction among the components.

Where scientifically appropriate, collaboration or
cooperation with other NIAID-funded projects and/or US government agencies, for
example CDC, FDA, and/or USDA.

2.A.4. Arbitration Process

Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be
convened. It will have three members: a designee of the awarded group,
one NIH designee, and a third designee with expertise in the relevant area who
is chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.

A final
progress report, invention statement, and Financial Status Report are required
when an award is relinquished when a recipient changes institutions or when an
award is terminated.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human Subjects Protection:Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (Phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local IRB rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):NIH is interested in advancing
genome-wide association studies (GWAS) to identify common genetic factors that
influence health and disease through a centralized GWAS data repository. For
the purposes of this policy, a genome-wide association study is defined as any
study of genetic variation across the entire human genome that is designed to
identify genetic associations with observable traits (such as blood pressure or
weight), or the presence or absence of a disease or condition. All
applications, regardless of the amount requested, proposing a genome-wide
association study are expected to provide a plan for submission of GWAS data to
the NIH-designated GWAS data repository, or provide an appropriate explanation
why submission to the repository is not possible. Data repository management
(submission and access) is governed by the Policy for Sharing of Data Obtained
in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information
Act:The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of Model Organisms:NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating that
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research. This policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43). All investigators proposing clinical
research should read the "NIH Guidelines for Inclusion of Women and
Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject Participants:NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria
for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final,
peer-reviewed manuscripts that arise from NIH funds and are accepted for
publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002 . The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The
Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The
PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law
103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

Loan Repayment Programs:NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov.